SUBCOMMITTEE ON STANDARDS AND SECURITY

September 26, 2007

Participants:

Jeffrey S. Blair, M.D.A., Co chairman

Harry Reynolds, Co-Chairman

Simon P. Cohn, M.D.

Judith Warren, Ph.D., R.N.

Denise Buenning, MSM, CMS

Marjorie Greenberg, NCHS

Steve Steindel, Ph.D., CDC

PROCEEDINGS

MR. REYNOLDS: I’d like to go ahead and begin the meeting. This is a breakout session for the Standards and Security Subcommittee, as the subcommittee of the full NCVHS. What we’ll do is go around the room and just introduce ourselves. And we’re not on the internet today, but we are being recorded. And we’ll move into our agenda.

I’m Harry Reynolds. I’m the co-chair of the Subcommittee and from Blue Cross Blue Shield of North Carolina.

DR. COHN: I’m Simon Cohn. Chair of the Full Committee and member of the Subcommittee.

MR. BLAIR: I’m Jeff Blair. I’m the co-chair.

DR. STEINDEL: Steve Steindel. Center for Disease Control and Prevention, staff to the Subcommittee and liaison to the Full Committee.

DR. WARREN: Judy Warren. University of Kansas School of Nursing, member of the Committee, member of the Subcommittee. No conflicts.

MS. BUENNING: Denise Buenning, CMS. Lead staff of the subcommittee.

(Introduction around room.)

MR. REYNOLDS: Okay. We have a few items today. The main one is the revision to our letter, which we had gotten some input during the meeting yesterday, and then Jeff and Steve and Judy were gracious enough to, at a time when the rest of us were other subcommittee meetings, spent time reworking it and I went over it with them this morning. And then the other thing we’re going to do is, we have already sent out for dates in January to have a hearing and I want to go through the kinds of things that we see coming up that we need to consider in that January time frame. And I would like discuss that. So we’re getting copies made of the letter, so if you want to, we can either start with the letter but everybody will have to look at the screen, or we can wait just a few more minutes and we will have copies. Everybody okay with the screen?

Okay. Jeff, I think it would be good, why don’t you just give a little idea of the input and everything that we had, what you guys kind of went through yesterday.

MR. BLAIR: Certainly. The first thing is, you know, Michael Fitzmaurice had suggested that we add a sentence to the end of the paragraph of the letter, and that of course was done. Plus, a tag line to begin with. And then essentially we skipped all the way down to the observation section, and if I recall correctly, observation one and those recommendations were left unchanged. However, we moved observation four plus those recommendations up, so that became observation two. And when we did that, we also removed — I believe it was the second paragraph that had gotten us confused yesterday, the second paragraph in the observation, which was going into the business case type issues.

MR. REYNOLDS: That was an observation point, Jeff.

MR. BLAIR: I’m sorry. Thank you.

MR. REYNOLDS: Keep going. I just wanted you to talk about the flow, you don’t need to be absolutely precise on every piece of it. I’m going to go through here in a minute.

MR. BLAIR: All right. Matter of fact, are you just about ready now with the handouts?

MR. REYNOLDS: No.

MR. BLAIR: Well, I think I’ve kind of summarized the focus of where those changes are. So observation one, the relocation of four to two, and that’s probably all we’ll focus.

MR. REYNOLDS: And this morning we did modify one sentence in there to bring up the return on investment, and we’ll show where that is.

Simon, were you going to make a comment?

DR. COHN: I was just being very concrete, and I realize that we have further wordsmithing and all of that but I do have to say that the title here doesn’t exactly send me.

MR. REYNOLDS: The tag line? Well, as a matter of fact, we don’t need copies to discuss a tag line, so let’s go. We’ll go ahead and start on the tag line.

MS. GREENBERG: I have a comment on that, also.

MR. REYNOLDS: Go ahead.

MS. GREENBERG: Because it’s not just required for ICD-10-CM, it’s also ICD-10-PCS, so I would say ICD-10 code sets, if you want to mention them in the tag line.

DR. COHN: Well, I guess I didn’t mean the tag line, but I mean, an improvement of what?

MR. REYNOLDS: Again, until you get the copies, go ahead and work this one. Let’s work it.

MR. BLAIR: Simon, I think you make a good point, and I think that maybe instead of referring to improvement of 5010, I think it’s the improvement to the HIPAA transaction standards.

Does that get closer to what you were trying to get to?

MS. GREENBERG: How are you using the language here in 1.2, which is to drive the industry toward standards harmonization and enhanced code standards? Everyone seemed to be okay with that?

MR. BLAIR: Yes, but everything does that.

MS. GREENBERG: What?

MR. BLAIR: Just about everything we do does that.

MS. GREENBERG: It was a little more concrete than improvement.

MR. BLAIR: Oh, I see.

Simon, maybe you could give us a little bit of a feel for —

DR. COHN: Paul is the wizard of the tag line here.

DR. STEINDEL: Don’t look at me. I don’t agree to the concept of tag lines.

DR. COHN: And you can decide not to put a tag line on this one.

DR. WARREN: Well, this is an example of why tag lines are hard, is by the time you write a tag line for this that represents what’s in the letter, you’ve written half the letter.

DR. STEINDEL: I don’t think tag lines add anything to the letter.

MR. REYNOLDS: Well, yes, but we’ve agreed to have them, so let’s don’t go there again.

MS. GREENBERG: Actually, our writer, who had just done an analysis of all of our documents and the consistency, or lack thereof, among them and our website and everything else, which I will discuss further with the Executive Subcommittee, and maybe we’ll have some discussion about it November, thinks that it’s a very good idea.

DR. COHN: It gives her a title to a letter, rather than just a date. We may want to say something like visions to HIPAA administrative transactions, administrative — what are they called — administrative transaction standards critical to further improvements in something or other. And to me, that’s more the tag line.

MS. GREENBERG: It’s true. A lot of people, when they see HIPAA, they think of privacy.

MS. BUENNING: Excuse me. Perhaps you can explain this. Is the purpose of this critical tag line to summarize the entirety of the letter, or is it just to kind of give it — just say this is, you know, 5010 recommendations, or what is the purpose in all of our correspondence of this tag line?

MS. GREENBERG: Just to let people know generally what the letter is about.

MS. BUENNING: So I guess if you’re going to say something like, recommendations for 5010 or whatever, just to summarize it, as opposed to trying to make a larger statement that kind of summarizes all of the recommendations.

DR. STEINDEL: If you want to be short and sweet, how about something like HIPAA transaction, set revision needed?

DR. COHN: I would go with that.

MS. GREENBERG: Revisions needed to HIPAA transactions.

MS. BUENNING: Okay. Let me just put that up there and see.

DR. STEINDEL: That’s short and sweet. It’s on one line. I think if you have a tag line it has to fit on one line.

MS. BUENNING: Could you repeat that, please?

MS. GREENBERG: Revisions to HIPAA transaction standards needed.

DR. BLAIR: Why do we need the “needed”. Why don’t we just say that these are the revisions to the HIPAA transaction?

MR. REYNOLDS: I can come up with one a little longer. I’d like to just throw one other one out there.

MS. BUENNING: You now should have in front of you all the copies of the letter that’s up here.

MR. REYNOLDS: All right. Here we go. So the paper we have in front of us, and you can look up at the screen, the first change we’ve made is at the end of the first paragraph. It was recommended, and you see it in red line up on the screen, “The purpose of this letter is to summarize these hearings and make recommendations.”

Move on until we have our next set of changes. Everybody can look at their paper to see it. It’s under “Observation 1”. It’s what you have in front of you, if you will read down to —

MS. GREENBERG: Where are we? Observation 1?

MR. REYNOLDS: Yes. Observation 1, pages 3.

DR. COHN: Can I speak to that, or do you want to say it first?

MR. REYNOLDS: No. Please go ahead.

DR. COHN: I guess I still wonder — and I think we heard pretty strongly yesterday, that this whole concept was maybe unnecessary for the letter. I know we keep sort of throwing in, well, we like this, but there is not a business case. And of course, I keep saying, well, geez, if there’s really no business case, we shouldn’t be bringing this forward. And so you’ve changed it slightly because of that lack of clarity, but if you really think there’s lack of clarity on the business — move away from business case, if business case means different things to everybody else, to different people.

I guess I would observe that if whatever you call it, the healthcare stakeholder community, had brought forth a bunch of things that they felt were needed, which would improve business process, that they must have thought that there was a business case for that. Now, whether or not it was somehow package by the 5010 X12 community for our purview is a whole different issue than whether or not that there is a business case. And so I guess I’m wondering why we’re trying to make this statement in the midst of an observation, which at the same time we’re suggesting that we go forward. I mean, if indeed we feel this is the case, let’s go and hold some more hearings and let’s get the business case. Two reasons.

MR. REYNOLDS: And again, the red is what I added this morning for the following reasons because what they wrote last night was, “While there is less clarity regarding the overall business case for adopting version 10, there was general industry support.” So that’s what they put in last night.

My issue continues to be, we wrote the lessons learned, and we keep talking about that there’s been no ROI. We said that going forth there should be ROI. We asked in the hearing what kind of a turn they thought there was, or any of the other things, what business case there really was. They come up with, and we won’t go into semantics, but they talked about business reasons that they cannot come up with dollar savings, how it would change the industry. I mean, it was basically, these are our adjustments.

And so I am comfortable taking it out, but as we look at the history, it’s a little bit like every time we’re doing something now, we’re referring back to the privacy letter that we did on NHIN and saying, okay, that’s what the committee said. So the committee is on record consistently now, and actually it had specific hearings on the fact that some of us at some point needs to start making —

DR. COHN: Can I make a suggestion?

MR. REYNOLDS: Absolutely.

DR. COHN: You know, I would be a little more comfortable if we said something along the lines of, while there needs to be more work done to further quantify the business case.

MR. REYNOLD: I’m fine with that. Thank you. I can go with that.

MR. BLAIR: And that was the word I was also going to suggest, is well, it’s not quantified, but intuitively people see a business case. And so I think you’ve hit the right word.

DR. COHN: It’s actually to further quantify.

MR. REYNOLDS: No, I’m fine with that. And again, trying to be consistent, because if we’re going to continue a glide path of significant change, which we talked about yesterday, whether it’s 5010, then ICD-10, then attachments, then this, then that, it’s a theme that we had in our —

DR. COHN: And let’s get rid of “including return on investments”.

MS. GREENBERG: You said quantify. To further quantify the overall business case. Okay.

DR. COHN: Get rid of “return on investment”.

MR. REYNOLDS: And just put a period after case.

Good. Everybody good with that?

PARTICIPANTS: Yes.

DR. COHN: Okay.

MR. REYNOLDS: I think that’s a good — it keeps our continuous theme, but it doesn’t beat it to death, and I think that’s a wonderful place to be.

Okay. On the next one, based on putting in that sentence — and, Mike, before you got here, we did put your sentence at the end of the first paragraph.

DR. FITZMAURICE: I was going to suggest a rewording of the “however” sentence up there to say, it was clear that in NPRM would provide impetus for the industry to begin planning for adoption of these updated standards. Instead of making a negative, make it a positive, that it was clear that an NPRM would provide the impetus.

MR. REYNOLDS: Rather than saying there would be little movement if you didn’t do it. I like that.

MS. GREENBERG: That’s true. It kind of makes the industry sound bad.

MR. REYNOLDS: I think that’s a good, positive statement.

DR. COHN: Do we need that last sentence at all, just because I guess in my view, I can’t imagine why the industry would move forward to a new standard that has to be regulated and put into regulation, unless there was an NPRM.

MR. BLAIR: The only thing is the testifiers ask us, so I think we need something.

MR. REYNOLDS: But our recommendation does move forward.

MS. GREENBERG: And it kind of explains why even though there needs to be more work to further quantify. As long as you’re going to have the sentence up there, then I think you need this one down here.

DR. COHN: So what are we saying here?

MR. REYNOLDS: Mike, go ahead and say your words again.

DR. FITZMAURICE: I would consider dropping the “however”, and just say it was clear than an NPRM would provide impetus for the industry to begin planning for adoption of these updated standards.

MS. GREENSBURG: Yes, now you don’t need the “however”.

DR. FITZMAURICE: For the adoption of these updated standards. And I would take out the “however”.

MR. REYNOLDS: Simon?

DR. COHN: You know, I guess you would say I’m not going to fall on my sword on this one, but it just, it sounds apologetic for the industry, and I don’t the industry needs to apologize about — I mean, what we’re saying is that we’ve reviewed the standard. We think that there is a reason to do it, and so we should go forward and if we don’t feel that way, then we shouldn’t be supporting this.

MR. REYNOLDS: So what you’re saying is, it’s a given that nobody is going to do a lot until there’s an NPRM, because nobody’s been asked to do anything, nobody is required to do anything, and there isn’t any date to do anything. So that’s what you’re saying?

DR. COHN: Okay.

PARTICIPANT: That’s pretty much an inherent process, and this is not a voluntarily adopted standard.

MS. GREENBERG: No. And in fact, they would be ill advised to do anything if it isn’t going to be adopted.

MR. REYNOLDS: And this is a little different than, for example, when the people within NCPDP came forward and the industry said, we’re already there. Remember when we had that one version that we recommended the backward compatibility? That was a significant — Judy?

DR. WARREN: Well, I have one question, because as I recall, the discussion went on in the testimony. I think a lot of the people said that it is important for the NPRM to come out before they would start anything. And that was repeated several times. So how faithful do we want to remain to that kind of request from the testifiers?

MR. REYNOLDS: The recommendation does stay truthful.

DR. WARREN: I meant the part that we now say we’re taking out, that the industry won’t begin planning anything until this is passed.

MR. REYNOLDS: Steve.

DR. STEINDEL: I was actually thinking the same thing as Simon brought the question of dropping that sentence, because it doesn’t reflect what we heard in the testimony. But as I recall the testimony more and more, the way I envision it was that statement was really in response to our questions that were, well, what if. And then we got responses back, well, we have not been given resources to look into it, and we won’t until there’s and NPRM. So what we were doing was, okay, what would be the impact of. So I agree with Simon. I think that sentence is somewhat superfluous.

MR. REYNOLDS: Judy, can you go there now?

DR. WARREN: I can go there. I just wanted to call up what we had heard.

MR. REYNOLDS: Marjorie?

MS. GREENBERG: I was just, I mean, it depends on how much you want to equivocate in the observation, but the recommendation is clear. I don’t know if you need this.

DR. COHN: You know the other way we can do this one is if we’re going to turn it into a positive statement, where we can say something along the lines of testifiers indicated that the publication of the NPRM is a critical first step. But that’s probably also superfluous.

DR. COHN: Can I ask you a question about 1.2, because isn’t parallel to 1.1. And I get a sense that there’s code in here that I don’t — I mean, maybe it’s missing.

DR. STEINDEL: Simon, I think we can actually now make it a parallel to the others, because those words were put in when we had all words in there about the business case.

MS. GREENBERG: You still have words about the business case.

DR. STEINDEL: But they’re not the same level of — we cut out that whole second paragraph.

MS. GREENBERG: I like 1.2 just the way it is.

MR. REYNOLDS: But let me ask you then, why wouldn’t be in 1.1?

MS. GREENBERG: Well, it could be. I don’t know about the Enhanced Code Standards for 1.1.

MR. REYNOLDS: Right. But in other words — because Simon kept reminding us yesterday and that was good. The industry is really okay with NCD.0, so it’s easy to just kind of say, we’ll just kind of do that and not make a big case of it. Then we go to 5010 and we go, big case. They’re both standards changes. They’re both significant changes in one way or the other, and it looks like we might be short-changing now.

MS. GREENBERG: It’s like what they call a Jewish compliment. It might be true, but it would better just to leave it unsaid.

(Laughter)

DR. STEINDEL: I was the one that actually separated the two, and I separated the two because we clearly stated in the material that we removed, that there was confusion with regard to 5010. And then we were clearly stating, go ahead and do it. And so I wanted a little difference in the two recommendations to show that there were other reasons. But now that we’ve removed that language, I think we can do exactly what you said.

MR. REYNOLDS: Unless I hear differently, the end of that is going off.

DR. STEINDEL: Just remove 1.2 and —

MR. REYNOLDS: Right after transaction. No. No. 1.2 stays in.

MS. GREENBERG: Yes. You can’t remove 1.2.

MR. REYNOLDS: You put a period after transactions.

DR. STEINDEL: You can now move as 1.1. The Secretary know the proposed rulemaking —

MR. REYNOLDS: Let’s leave it separate. Put a period after transaction. Okay. Everybody good with that?

All right. Moving along.

DR. STEINDEL: Okay. Observation 2 is the previous observation 4. It was moved up to this area for flow reasons. And the introductory sentence of the previous observation 3 was made — introductory paragraph for the previous observation 3 was made the introductory paragraph for this observation 2.

MR. REYNOLDS: Okay.

DR. COHN: I think that the flow actually worked better. I do think that we need to say something in here about NCPDPD.0, since the observation doesn’t reference it. Here we are talking about both standards and somebody was talking about 5010. It may be an early sentence that says, yes, we heard that there really were no implementation issues regarding the NCPDPD.0.

MR. REYNOLD: I think that we should say that first, because that, again, it was clean throughout the testimony and it was clean throughout everything else, where the big discussion on timing and other things was around 5010. So I think it would be good to put it up there.

DR. WARREN: Even though there is no recommendations about NCPDP in this?

MS. GREENBERG: There may have to be one.

DR. STEINDEL: Well, it did.

DR. COHN: Well, I just think it seems very odd to be talking about both, and then suddenly only talking about one where it isn’t even referenced in the observation and just not say anything about it.

MR. REYNOLDS: Denise, go down to the recommendations for just a second.

DR. STEINDEL: The recommendations focused just on 5010.

MR. REYNOLDS: If you consider establishing implementation period for two different — why doesn’t recommendation 2.1, why isn’t that timing, not the last sentence of it, but why isn’t the timing in the level one and the level two the same for NCPDPD.0, 5010, ICD-10, attachments? Why isn’t that process of level one, level two, why doesn’t it fit for every standard we’re going to do going forward?

DR. WARREN: I think resequencing these surfaces those questions, because we didn’t change this at all.

MR. REYNOLDS: I know you didn’t.

DR. WARREN: And so now we’re able to see that there’s a glitch.

MR. REYNOLDS: We’re talking about a structure of level one, level two, whether the secretary decides for — if the secretary decided for NCPDP, level one is one year and level two is the second year, so that’s only two years. And the vice versa for something else, everything else.

DR. COHN: I’m going to ask here. Do we do D.0, before we do 5010, before we do ICM?

MR. REYNOLDS: No. They can be done concurrent.

DR. COHN: Okay. We can do that because —

DR. STEINDEL: If we do different segments of the industry.

MR. REYNOLDS: Well, what I’m saying is, they can be done. See, different than our glide path, we were talking about the other things.

PARTICIPANT: So we do 5010, ICD-10, claims, attachments. That’s changing the exact same things in everybody’s business.

DR. COHN: So we need to add something about segment of the industry. I would agree that there are probably some people in pharmacy would make the argument to you that there are some of the 5010 transactions that do apply to pharmacy, and claims attachments might — and I don’t know that the pharmacy will use that, but there are some transactions that a pharmacist might use.

MR. REYNOLDS: But I’m saying the NCPDP format itself doesn’t effect all the other transactions. That’s what we’re saying.

MS. GREENBERG: Could you implement D.0 one year and 5010 the next?

MR. REYNOLD: Yes.

DR. COHN: They were simultaneously.

MR. REYNOLDS: It’s simultaneously. Absolutely.

I don’t think they actually interface with each other at all.

DR. FITZMAURICE: It wouldn’t be mandated to the trading partner agreement.

MR. REYNOLDS: So the reason I think we really focused this whole level one, level two on 5010 was because it changes all these transactions for whole entities.

DR. COHN: Okay.

MR. REYNOLDS: Whereas the NCPDP, I would say there’s an awful lot of the covenant entities would even get involved in. A lot of that is just the pharmacy industry passing stuff back and forth.

DR. COHN: I just have a thought here, just to try to keep things simple because I think we’re going to drive ourselves crazy down here. If in the observations we’re sort of saying, geez, we heard no implementation issues with D.10. It affects the pharmacy community. The following observations and recommendations apply, you know, and I’m trying to give it the right words here, primarily to — I mean, very specifically to users of X12 transactions, or something like that.

PARTICIPANT: I like that.

MR. REYNOLDS: Well, because basically, we heard no issues from anybody related to that about sequencing or anything else.

MS. GREENBERG: So if this idea of these different compliance levels is adopted, you’re saying this shouldn’t apply to the NCPDP?

DR. COHN: Well, maybe you’re right. Maybe this does need something in the recommendations since we don’t know what the future will hold.

MS. GREENBERG: I think what you can do is make your first sentence about — issues, then go on. And then you would have to remove the last sentence of recommendation 2.1 from 2.1, and if you wanted to continue to make it, you could include it as a second sentence in 2.2 and then you could discuss that.

MR. REYNOLDS: Okay. I think that’s a good idea.

MS. GREENBERG: So make the compliance level recommendation generic. And don’t say anything in there about D.0 or anything.

MR. REYNOLDS: 5010 or anything, yes.

MS. GREENBERG: Anything.

MS. BUENNING: Did I get that correctly?

MR. REYNOLDS: Yes.

All right. Jeffrey, let me help you out here. Do you want me to read the two recommendations now so that you’re okay with that?

MR. BLAIR: Yes. Thanks.

MR. REYNOLDS: Okay. Recommendation 1, “HHS should consider establishing implementation periods for two different level of compliance. Level 1 compliance would mean that the covered entity could demonstrate that it could create and receive compliant transactions. Level 2 compliance would demonstrate that covered entities had completed end-to-end testing with all of their partners.” Period. End of recommendation.

MS. GREENBERG: I mean you could have six months for this.

MR. REYNOLDS: Absolutely. That’s up to the Secretary.

“Recommendation 2.2: The implementation of Version 5010, ICD-10 and claims attachments should be sequenced that no more than on implementation is in Level 1 at any time. HHS should also take under consideration industry feedback indicating that for Version 5010, two years will be needed to achieve Level 1 compliance.”

MS. GREENSBURG: But it still gets us into doing the math.

DR. FITZMAURICE: Harry, on number 2, suppose somebody wants to do two at one time? This would say that we’re recommending that you mandate that no more than one be at Level 1 at any time. And we want to give them freedom and flexibility.

DR. WARREN: We also don’t want to mandate that they do something that they can’t achieve, so that we’ll have to keep issuing extensions.

DR. FITZMAURICE: That’s going to happen anyway, in my opinion.

MS. GREENBERG: If you figure that 5010 includes ICD-10. Now, I can see where you wouldn’t want to do 5010, ICD-10 and claims attachments all at the same time. That would be —

DR. COHN: I didn’t hear any testifier indicating that ICD-10 is part of 5010.

MR. REYNOLDS: The place to put a number is in 5010. Just a place to put a number is in 5010.

MS. GREENBERG: Yes. Well, a lot of people said that’s really the big thing with ICD-10, is that it’s longer and it’s alphanumeric and you’ve got to make all those changes and everything. We have to do that for 5010.

MR. REYNOLDS: No. I don’t feel you do.

MS. GREENBERG: You don’t have to accommodate that?

MR. REYNOLDS: No. The reason is, you’re not going to use it until you go to ICD-10. You can set the field up, the field is set up, but you don’t have to put any logic in there. You don’t have to do anything with it because you’re not going to fill it. It’s when you fill it and start adding all the business rules around filling it, is when you do ICD-10. So all you’re doing now is, you’re just expanding a database and leaving a field there, but you’re not really putting any logic of any significance at all around it until you start putting a number in there.

DR. WARREN: But that in itself is quite a task, which is why you need to separate the two.

DR. FITZMAURICE: Harry, on the recommendation 2.1, we say, HHS should consider establishing implementation periods for the two different levels of compliance. Then we go into defining the levels, but we don’t define the periods.

MR. REYNOLDS: Purposely.

DR. FITZMAURICE: Okay. So we don’t know how long they should be.

MR. REYNOLDS: Remember we don’t know what’s coming. We don’t know how big, how small. You could run into a situation on something where maybe the secretary would say that it’s going to take two years for Level 2.

DR. FITZMAURICE: Okay. I see what you’re saying.

MR. REYNOLDS: All we’re saying is, we’re not — just like with some other things, people push back on this. We’re not trying to be overly descriptive and say, everything is one size, everything is one way. We’re talking about some kind of structure so that people have a glide path as to how things are going to flow.

MR. REYNOLDS: Simon.

DR. COHN: Could I just ask a question? Maybe the end of the first sentence of 2.1. We’re actually talking about two different levels of compliance for HIPAA transaction standards and code sets.

MR. REYNOLDS: Yes. I think that’s correct.

DR. COHN: Or is it the transaction standards – I’m not really sure what – I mean we are doing something like that just to qualify it.

MS. GREENBERG: What is that?

PARTICIPANT: Specify the transactions and code sets.

MS. GREENBERG: Oh, two levels of compliance.

DR. COHN: It’s actually — is for the implementation of or is just for HIPAA?

Denise, help us with that one.

DR. STEINDEL: When implementing?

MS. BUENNING: We already have implementation. I’m struggling. Do you actually want to have, when you say, “HHS should consider establishing implementation.” Do you want to say, HHS should consider establishing two different levels of compliance, as opposed to the periods?

MR. REYNOLDS: It’s compliance. It’s two levels of compliance.

MS. BUENNING: Okay. So let me work on that first.

MR. REYNOLDS: See, one of the things that this allows is people can start complaining about each other. The problem is there’s no jurisdiction. During the first few years of anything right now, there is no jurisdiction, even though exactly what happened happened.

MS. GREENBERG: Well, I’m willing to accept the concept that there should be no more than one implementation is in Level 1 at any time. If you leave flexible the time periods at these levels.

MR. REYNOLDS: It’s not listed in there except for 5010, which we have heard testimony on. So that’s why we didn’t say that about anything else, even go any further than that.

MS. GREENBERG: Well, I still say get back to this ridiculously long time period, then, if you make this statement.

DR. FITZMAURICE: Suppose in recommendation 2.1 where we say, “HHS should consider establishing implementation periods for two different levels of compliance,” we say, HHS should consider establishing maximum implementation periods, that is, here’s the maximum length of the implementation period.

DR. WARREN: Oh, but people will go to the maximum length.

DR. FITZMAURICE: The point is, if it’s they’re not maximum, if this is the length of time you have. If that’s not the maximum you have, what does it mean, this recommendation?

DR. WARREN: Because they also get extensions, so it’s not a maximum. And all we’re saying is, you’ve got four years to do this. Everybody is going to wait until year three, and then do it, and then we’re going to need another two years because they won’t get it done in year three.

MR. REYNOLDS: Marjorie, in response to your question, go ahead, Judy.

DR. WARREN: Going back to Marjorie’s thing – I’m still struggling with the fact that I think to implement 5010, this first part, it really is going to take people two years. I think we were pretty honest with that. When I look at some of the changes they have to make in order to do that, I think phase one is going to create that. But I understand Marjorie’s concern that it really puts 5010 off into the future —

MS. GREENBERG: ICD-10.

DR. WARREN: ICD-10. I’m sorry. I don’t know how to shorten that any, because 5010 puts some serious constraints up front. So unless we can figure out how to shorten what comes after —

MR. REYNOLDS: This does shorten it.

DR. STEINDEL: At least this keeps it on schedule.

MR. REYNOLDS: Not according to what Marjorie wants, but I am saying as far as —

MR. GREENBERG: Well, I have not heard — even your organization, Harry, has come out for 2012, and you said 2013 —

MS. GREENBERG: I know, but you said, what Marjorie wants, so I had to tell you —

MR. REYNOLDS: I’m going by what you just said. I’m using your words. I’m not putting words in your mouth. I’m using your words. We want it faster. Let me say what this does.

What this does is, at the end of two years or one year, whatever the Secretary decides Level 1 has done for 5010, you can start the time frame on ICD-10.

MR. BLAIR: Yes.

MR. REYNOLDS: Let’s go back to the current world, which I will do implement in the current world, and I do implement every one of these in the current world. Right now for MPI, it is going on forever.

MS. GREENBERG: Part of that was the department’s fault.

MR. REYNOLDS: And the transactions are still going on forever, because some of those aren’t implemented. And there’s still contingencies for some of those. So my point is, this allows a faster official start, whether it’s ICD-10 or claims attachments or anything else. And this ain’t about me, and this ain’t about my company, and ain’t about nothing other than if I am sitting there because this — whatever happens will be handed to me. And I don’t decide a lot of this stuff. And I know that I have to be done with changing my systems, whatever Level 1 takes, so that I can start changing my systems for Level 2. Or I mean for the next Level 1. That’s what this says.

MR. BLAIR: It is my sense that all of us want this to move as quickly as possible. In addition to us wanting it move as quickly as possible, we also don’t want to put ourselves in a position where there’s additional slippage. So the way that this is constructed is not only to have it move it as quickly as the industry has said we can move, but also to set a process where we can keep them on target to stay on those days.

MS. GREENBERG: Well, I also agree with Larry, that use of the term “health industry” means the people you had at that hearing.

MR. REYNOLDS: Fine. We’re testifying.

MS. GREENBERG: At least you got to say, those who testified told you that, because you didn’t have people there to react to implementing ICD-10 code sets in 2013.

DR. COHN: Let me do a future hearing —

MR. REYNOLDS: Right. But let me touch base on that. I was asked for an example yesterday. I was not recommending anything. But if you went with two, one, two, one, as has happened in the past, that’s what it would be. Now, we don’t have a date up there that says it can’t be Level 1 in six months.

MS. GREENBERG: Oh, but you said years.

DR. COHN: Well, actually, there’s no reason why it has to be two one, it can be two, two, two.

MR. REYNOLD: That’s what I mean. It doesn’t matter what it is.

MS. GREENBERG: Four years now, instead of the two years in legislation?

DR. COHN: No. What I’m saying is this, what we’re saying here is that it might take two years in Level 1 for 5010, and take two years for ICD-10 potentially. You have to realize this, as the executive director of the committee, you realize that in 2003 we recommended ICD-10 implementation. So I would suggest that we really aren’t part of the problem, with the fact that the implementation has not occurred in a more speedy fashion.

MS. GREENBERG: I agree with you on that.

DR. COHN: And really, what we’re trying to do here is, I think we are actually being consistent with what we heard, specifically on ICD-10.

MR. REYNOLDS: 5010.

DR. COHN: 5010. ICD-10, as I said yesterday, I really think needs to be a — I mean, we’ve already made a comment about it. We have written a letter to the Secretary. I think based on your comments, as well as letters we received, I think that needs to be part of another hearing where I should talk about the implementation framework for ICD-10.

I think from view, if we don’t get this thing — and you can certainly hold this letter off until November.

MS. GREENBERG: No, I don’t think —

DR. COHN: No. I’m just saying, if we’re going to get this all right before we can do anything, that’s the answer.

MS. GREENBERG: You can’t pass the two of the.

MR. BLAIR: Let’s just focus on this one right now. We’re doing the SSS meeting right now. Let’s just try to get this done and get this one passed. Let’s move as quickly as we can.

MR. REYNOLDS: Steve.

DR. STEINDEL: It’s my fairly strong feeling that at the hearings that this letter represents, we heard nothing about the implementation of ICD-10, except that it requires 5010. That’s was all.

MS. GREENBERG: And not to those people.

DR. STEINDEL: Wait a minute Marjorie. And I agree Harry and Simon, and I felt this during the hearing. We need another focused hearing that addresses the implementation staging of ICD-10 with respect to what we’re recommending for the staging of 5010, to try to expedite that implementation. And I can see, you know, within this framework, we’ll probably hear testimony to be consistent with our previous recommendations. After we hear the testimony we’ll probably say something like, the Secretary should proceed expeditiously with the implementation of ICD-10.

And building on this letter, what we will say in that letter specifically, that Level 1 testing for ICD-10 should start immediately upon the conclusion of Level 1 testing for 5010.

MR. BLAIR: Yes. And if that happens, if you wind up saying two years and two years, just like Simon said, then my math says that it’s either 11 or 12, not 13, if HHS acts. So this does not preclude — if HHS acts expeditiously on this, we can be faster.

MS. GREENBERG: I mean if HHS wanted to, they could get a final ruling for 5010 out in 2008.

DR. STEINDEL: But there’s nothing we can do about making HHS act, except hold some hearings and write the letter.

MR. BLAIR: But what we can do is get this letter out as quickly as we can.

MS. GREENBERG: I’m all for getting this letter out. And if you change that sentence to “feedback from the testifiers.” If that’s what you heard, fine. I just think it’s too broad to have industry feedback.

MR. REYNOLDS: Then I would want it to be consistent in other NCVH –.

MS. GREENBERG: You were put on the spot yesterday, and it’s unfortunate, probably, that you know, you were going to try to be responsive to another member. But this 2013, I must say, to me, is very problematic.

MR. REYNOLDS: Well, fine.

PARTICIPANT: But not here in the letter.

MR. REYNOLDS: No, it’s not there.

MS. GREENBERG: No.

MR. REYNOLDS: And the other point is, as a member of the committee, you ask doctors to state as implemented, on what they do. We ask lawyers to say what they do. I have implemented, ever since HIPAA existed, what happens. And so I’m talking about what testimony you will hear from — you call them the industry, you can call them whatever it is, because ICD-10 will be the largest of the implementation changes that we have faced. I can tell what Nina(?) showed me, who was one of the advocates of it. So I get to be — so just like doctors get to be doctors, I get to be an implementer. And so therefore, I have stated a fact as the only implementer in the room of significance, and I have a right to be the expert on that.

(Laughter)

MS. GREENBERG: All right. You’re the expert.

MR. REYNOLDS: Now, whether people agree with the direction, the purpose, or the structure, is a big difference.

MS. GREENBERG: How about the committee coming out and saying there should be a final rule on 5010 in 2008? The Department should do it. Absolutely.

DR. WARREN: A final rule.

MS. GREENBERG: What?

DR. WARREN: A final rule.

MS. GREENBERG: A final rule. Not just the notice of proposed rulemaking, but a final rule. And they won’t listen to you anymore maybe than they did when you said publish the —

MR. BLAIR: I don’t know that we’ve ever wound up picking a date for any of these things.

MR. REYNOLDS: Should we use the word — what about expedite?

MR. BLAIR: Expedite. Yes. I’d like to see it as soon as possible. Definitely.

DR. WARREN: I need to ask a very naïve question. Given the political environment that will be occurring in 2008, do we really expect a final rule?

MR. REYNOLDS: It doesn’t matter. We have a good recommendation. We have a good glide path. We have a good structure.

DR. WARREN: I don’t like putting a year in there.

MR. REYNOLD: Well, let’s put expedite then. Because we really do believe and we heard from —

MS. GREENBERG: Did we hear any reason to —

MR. REYNOLDS: No. That’s what expedite means.

DR. STEINDEL: Harry, you mean in 1.1 —

MR. REYNOLDS: In 1.1 and 1.2.

DR. STEINDEL: — the secretary should expedite the development of?

MR. REYNOLDS: That’s correct. Yes.

(Discussion)

MS. GREENBERG: Or you could say develop. I mean, you could say rule making. Expedite rule making to adopt — because we get a notice of proposed rulemaking for claims attachments, what, about three years ago?

MR. REYNOLDS: So what are you thinking we should say?

DR. FITZMAURICE: We could urge the first step, which is the NPRM. At some time we could revisit and say, now the NPRM was revisited and it’s been a year since it’s been out there.

MR. REYNOLD: So is expediting the development an issuance of an NPRM?

PARTICIPANT: I’m sorry, is there a change —

MR. REYNOLDS: To all three of them.

MS. GREENBERG: Oh, to all three of them.

MR. REYNOLDS: To expedite the development and issuance –

MS. GREENBERG: One thing you might do is have a top sentence and have 1.1, 2 and 3. So recommendation 1 is the Secretary should expedite the development, unless you just want to — what I’m saying is, it gets a little repetitive. You just want to say A, B, C. But I guess you could have separate ones.

DR. COHN: That level we can deal with at the end of the subcommittee.

MR. REYNOLDS: Are we back to two, now? Any other comments on two?

DR. COHN: Well, actually, and it really isn’t part of two, but it’s actually a final — we need to say somewhere, based on all of our conversation, we probably do want to tell the Secretary that we are planning to hold a hearing related to implementation of ICD-10.

MS. GREENBERG: Do you want to say time frame, so it doesn’t look like you’re reopening.

DR. COHN: Okay. Timeframe.

MR. REYNOLDS: Moving on to observation 3.

DR. STEINDEL: After comment, observation 3 is the previous observation 2, with first paragraph removed. And that actually appears in the now present observation 2.

MR. REYNOLDS: Okay. So it wasn’t removed. It was moved?

DR. STEINDEL: Right.

MR. REYNOLDS: So observation 3 is just shortened quite a bit. Let’s go through the recommendation. “HHS should develop a plan to work with the industry and the standards organization to collect and analyze requirements related to testing, including defining the process of pilot testing, determine under what conditions pilots should be conducted, and when this testing should take place.”

And pilot testing is consistent with other letters we have submitted.

DR. COHN: Can I ask another question about D-10? Does this relate to D-0 at all, or is this a specific D-10 recommendation?

MR. REYNOLDS: This is a recommendation that really doesn’t have anything to do with — I guess it does with 5010, but it’s kind of a general recommendation forever and ever. Kind of one of those ever and ever, halleluiah.

DR. COHN: I agree. I see the first sentence of the observation 5010.

MR. REYNOLDS: Maybe we ought to take 5010 out.

DR. COHN: Yes. Okay.

MS. GREENBERG: What?

MR. REYNOLDS: In other words, were making —

MS. GREENBERG: Take that out?

MR. REYNOLDS: Just take the numbers 5010 out. We’re just talking about that we believe that there’s got to be some structure going forward on pilot testing and, for example, if you took something like ICD-10, you could start pilot testing just like they had did attachments well in advance. You could start pilot testing those things and get them going.

MS. GREENBERG: Yes.

MR. REYNOLDS: Again, what’s neat about this letter is that we’re setting up a structure that is going to allow some kind of a glide path going forward as the right things to do as we do them.

DR. COHN: Harry, I agree with you. What is the first sentence we need to look at? Because I don’t think software mechanisms left there is — I think just end to end testing and then we need pilot the use of — I mentioned about the software mechanisms.

DR. WARREN: Period after testing.

MR. REYNOLDS: Just testing of system changes, I think we ought to — and testing of system changes.

DR. WARREN: Okay.

MR. BLAIR: So you’re taking software mechanisms out?

MR. REYNOLDS: Yes.

MR. BLAIR: Good.

MR. REYNOLDS: And then we talk about pilot testing, and then have two recommendations. The first one talks about pilot testing and the second one, 3.2, “HHS should advocate the use of compliance testing services for software and/or applications that would demonstrate a covered entity’s ability to create and receive compliant transactions.”

DR. COHN: Now, I’m just curious because actually I think that first one is not system changes, because it’s a precursor to end to end. oh, I see. Okay.

MR. REYNOLDS: Now, just so that everybody in the Committee is completely aware of this 3.2, for example, there were such testing services as Clarity and Edifax and others that were offered, in some cases, nationally. providers and everybody could test against the same set of rules and move at their own speed, but knowing that they were compliant, which allows the industry to move. Because our goal, again, is to try to move the industry along faster, not make it everything one of, as we move.

So let’s go to number four, “Outreach to all stakeholders is critical.” Were there any changes?

DR. STEINDEL: No. That’s the old, I think, observation 2.

MR. REYNOLDS: For sequencing, we just moved that now.

DR. WARREN: We thought it was better to talk about all the testing and everything else —

MR. REYNOLDS: Yes. We talked about everything in every situation.

MR. BLAIR: Is in inappropriate — Harry, you just felt the need to explain what we meant?

MR. REYNOLDS: Yes. No, I was just making it clear that everybody —

MR. BLAIR: I understand. And I think that that was an appropriate thing to do. And since we know that, we we’ve written this. Do you think that we need to have a parenthesis on that one indicating such as Clarity, Edifax, et cetera?

MR. REYNOLDS: No. I would not want to go there.

Simon.

DR. COHN: You know, I mentioned in reflecting on a comment made yesterday and I’m looking in the observation in the second paragraph.

MR. REYNOLDS: On four?

DR. COHN: Yes. Where it says — talks about talking points and slide presentations and people thought that was a little too micromanaging.

MS. BUENNING: In the previous version as of yesterday, we actually changed that to “presentation material.” Kind of leave it generic.

MR. REYNOLDS: Are we willing to go there? Instead of taking it completely out, Denise is calling it “presentation material”.

MR. REYNOLDS: Another need identified is that of presentation material, which summarizes —

DR. STEINDEL: What about just the development of presentation material? Just take out those sentences and make the thought as — summarize the thought as presentation material.

MS. BUENNING: Another need identified is that of the development of presentation materials.

MR. STEINDEL: Yes.

MR. REYNOLDS: We could call it collateral made available to all industry stakeholders.

DR. STEINDEL: Yeah. And in the last part of that second sentence.

MS. BUENNING: Are we stopping after materials and then this.

DR. WARREN: Go up one line. Another need is to, so take out “that of”.

MR. REYNOLD: Do we even need this here?

DR. STEINDEL: I’m just responding to it being there. I personally —

MR. REYNOLDS: I think if you go back up there and where it says, “is available for dissemination,” if we said, “and is disseminated.”

MS. BUENNING: Okay.

MR. REYNOLDS: And is disseminated. So we’re not just making it is disseminated, then they can figure out whether that’s a presentation. Just put disseminated. Do you see where it says, “for dissemination”, right there and keep going. Then I think you take the whole next sentence out.

Everybody good with that?

(Several affirmative answers)

DR. FITZMAURICE: Do you want to say, and disseminate this information, or is it disseminate the data or both?

MS. BUENNING: How far are we going here in taking out?

DR. COHN: And I have trouble with the end of the first sentence here.

MS. GREENBERG: What? And disseminate this information?

DR. COHN: Well, the first sentence sort of ends wrong.

MS. GREENBERG: I think, and make it available for dissemination, is okay.

MR. REYNOLDS: Everybody good with that?

DR. FITZMAURICE: The analysis or the information?

PARTICIPANT: All the above.

MR. REYNOLDS: Okay. There were no more changes on the recommendations or the — Steve?

DR. STEINDEL: Right.

DR. COHN: Do you want to say something about ICD-10?

DR. STEINDEL: The hearings.

DR. COHN: Yes. Do we want to put that in?

DR. STEINDEL: Harry just asked me if we made any changes in the recommendations, and we did. Now were at the really lengthy last paragraph. “The NCVHS appreciates the –”.

: Right. Do you want to add to that?

DR. STEINDEL: Yes. That’s exactly where we’re going right now.

MR. REYNOLDS: So now do we want to add something on — Simon, back to your point, that we will be holding hearings?

MR. BLAIR: Why do we need to put that in a letter? That’s up to us. We don’t need permission from HHS to do it.

DR. STEINDEL: We’re not asking for permission.

MS. GREENBERG: I thought it was just more that we were going to complete the analysis.

DR. STEINDEL: There’s so much that we do.

MS. GREENBERG: The only thing is, if you have this letter coming forward from Quality and you have your, you know, it might just say, kind of indicate well, we realize there’s some issues here, you know, moving this all forward expeditiously. I’m fine as long as it doesn’t sound like you’re reopening the issue of whether.

MR. REYNOLDS: No. What we’re saying is that in January NCVHS will begin hearings on the implementation considerations of ICD-10.

MS. GREENBERG: No. Implementation schedule, maybe, or time frame.

MR. BLAIR: I just don’t feel like —

MS. GREENBERG: Maybe you better leave it off.

MR. REYNOLDS: Is everybody okay leaving it off?

Good. Okay.

Now, let’s go to January, and here are the things that we —

MS. BUENNING: Excuse me. Harry, before we go to that, the letter is done?

MR. REYNOLDS: Yes.

MS. BUENNING: Okay. What I’m going to do is I’m going to save it in this changed version, make a clean copy of it, and then you want this for dissemination to the Full Committee this morning?

MR. REYNOLDS: Yes. Simon, do you want any red line or do you want —

DR. COHN: So how are you going to describe to them all the changes?

MR. REYNOLDS: Let’s do this. Denise has a red line copy that we have, we can say, you have a clean copy in front of you. I’ll point out to you some of the things we did on the screen. But if we give them a red line and we start talking them having this in front of them and moving stuff around, it’s going to get a little —

MS. GREENBERG: Like I thought that was all new language and it turns out it was just that you moved it.

DR. COHN: Fine.

MR. REYNOLDS: Are you okay with that?

DR. COHN: Sure.

MR. REYNOLDS: Again, we’ll have it up there if people really want to get real interested in playing with the words.

So for January, Denise and I and Jeff got to together just briefly and the subjects that we obviously have is obviously NPI is still out there for us all. Back to my earlier points, maybe forever and ever. We always have a responsibility on anything related to HIPAA. We don’t have anything right now that relates to that.

Streamlining. We will close the gap on this whole streamlining discussion in the January hearing, if it’s nothing more than a mention to everyone as to what we had or hadn’t done. And we’ve mentioned, streamlining here some, but you know, in other words, to kind of close it out with the people we heard testimony on. That we did not ignore them. We understand that, and how we’re doing it.

E-prescribing NPRM will probably be ready for us to have some involvement in in January. We don’t think we’ll have anything on attachments. We will have ICD-10, and especially, I’ve had recommendations that we also hear from NUVC, NUCC and ADA, as it relates to ICD-10 also, along with any other testifiers that we want to have.

So I would think that if we focused, you know, and had an update on NPI, because remember, the contingency runs out in — the most recent contingency runs out in May of ’08, as far as an implementation, so it would be good to hear where are we, how we’re doing and what’s it mean.

Steve.

DR. STEINDEL: This is just in regards to schedule, so when you get finished.

MR. REYNOLDS: So that – e-prescribing an ICD-10 would be a good — kind of make sure that we were able to give each of those a good period of time. Now, we’ll see what else — anything that comes up in the meantime, but those would be the three main focuses for January.

Steve, do you have a comment?

DR. STEINDEL: Two comments. First comment, do we actually have dates?

MR. REYNOLDS: Yes. January 29th and 30th; everybody is “yes.” January 22nd and 23rd; only Justine is “no.”

DR. COHN: Just be aware that the 22nd is a day after a federal holiday.

MR. REYNOLDS: And we will be meeting on the 29th and 30th of January.

DR. STEINDEL: Right. We don’t have any other dates set?

MR. REYNOLDS: Not right now, no. We wanted to make sure we got this on in place, then we’ll start —

DR. STEINDEL: My other comment was in terms of schedule, what I noted to you earlier was at the HL7 meeting, Maria Ward came up to me, we met accidentally, and what I found out there, as we’re aware, she’s one of the co-chairs of the HL7 claims attachment technical committee. And they have three solid return on investment use cases for claims attachment that she would like to present to NCVHS, and I told her that I think Harry would be very excited about that and I would bring it up and see if we could put it on the schedule.

MR. REYNOLDS: Jeff, what do you think?

MR. BLAIR: Yes.

MR. REYNOLDS: So let’s make that as our fourth.

MS. GREENBERG: I did observe in the past that the week of the 29th is the X12 meeting, which I don’t go to X12, my staff do, but if you were saying that NUVC and some other people want to testify, that depends. Like George Ardis(?) — I think Todd Augmenson(?) goes, I know he goes X12, but George Ardis maybe doesn’t. So it’s something to keep in mind.

MR. REYNOLDS: The other thing that I would like you to help maybe Jeff and I with, Marjorie, is what are the types of things that you think it would be best for us to hear right out of the barrels, picking this up again, so that we can help move this process forward and so on?

MS. GREENBERG: You mean regarding the ICD-10?

MR. REYNOLDS: That would be correct. If you help us just with kind of what you think that flow might be that would be very beneficial to us.

MS. GREENBERG: Okay.

MR. REYNOLDS: With that, is there any other business?

DR. COHN: Well, just going back to the January dates. Judy, do you know when HL7 is?

DR. STEINDEL: No, it’s earlier.

DR. COHN: It’s earlier in January?

DR. WARREN: I think I have it on my calendar. I know it’s earlier. It’s not at the end of the month.